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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
Directive 96/54/EEC, B.1tris
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: EPA Health Effects Test Guidelines, OPPTS 870.1000 Acute Toxicity Testing EPA 712-C- 98-189, August 1998.
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Testing Methods for New Chemical Substances according to the Revised Japanese Chemical Substance Law (March 31, 1987).
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Batch: C02421 -1620
Purity: 98.6%

Test animals

Species:
rat
Strain:
other: rat, HanBrl: Wist (SPF)
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source:RCC Ltd, Laboratory Animal Services CH-4414 Fullinsdorf / Switzerland
- Age at study initiation:12 weeks
- identification: Unique cage number and corresponding color-coded spots on the tail. The animals were marked at acclimatization start.
- randomization: Selected by hand at time of delivery. No computer generated randomization program.
- Housing: In groups of three in Makrolon type-4 cages with wire mesh tops and standard softwood bedding (’Lignocel’ Schill AG, CH-4132 Muttenz Switzerland).
- Diet: Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 4/03 (Provimi Kliba AG, CH-4303 KaiseraugsVSwitzerland) ad libitum. Results of analyses for contaminants are archived at RCC Ltd, Itingen.
- Water (e.g. ad libitum):Community tap water from Fullinsdorf ad /jbjtum. Results of bacteriological, chemical and contaminant analyses are archived at RCC Ltd, Itingen.
- Acclimation: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
Standard Laboratory Conditions. Air-conditioned with 10-15 air changes per hour, and continuously monitored environment with target ranges for room temperature 22 +/- 3 °C and for relative humidity between 30-70%. (values above 70 % during cleaning process possible), 12 hours fluorescent light/12 hours dark, music during the light period.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Three female rats received a single dose of the test item by oral gavage administration at 2000 mg/kg body weight after being fasted for approximately 18 hours (access to water was permitted). Food was provided again 3 hours after dosing.

The application volume was 10 ml/kg body weight.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Mortality:
No deaths occurred during the study.
Clinical signs:
No clinical signs were observed during the course of the study.
Body weight:
One female animal showed a loss of body weight (0.6 %) between test day 8 and the end of the observation period. The body weight of the other animals was within the range commonly recorded for this strain and age.
Gross pathology:
No macroscopic findings were recorded at necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The median lethal dose of ucb 6474 after single oral administration to female rats, observed over a period of 14 days is: LD50 (female rat): greater than 2000 mg/kg body weight